Manufacturing: Biotechnology Industry
The term biotechnology is a very broad term that can be associated with many industries, such as: Industrial Biotechnology, Medical Biotechnology, Marine Biotechnology, Environmental Biotechnology, Law, Ethics, Philosophy, Food Biotechnology, Biological Warfare, Bioinformatics, Desert Biotechnology.
What is Biotechnology?
Wikipedia: “any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific use”
What are Biopharmaceuticals?
Wikipedia: “any pharmaceutical drug product manufactured in, extracted from, or semi-synthesized from biological sources”
What is Bioprocessing?
Pharma IQ: “any process that uses complete living cells or their components to obtain desired products”
Trend: products are becoming more complex (1/2)
Biotech vs Conventional Pharma
Trend: products are becoming more complex (2/2)
The portion of Biotech products is increasing
Manufacturing Processes Overview: Biotech vs Conventional Pharma
1 – Conventional Pharma Manufacturing: chemical synthesis for drug manufacturing
2 – Biotechnology Manufacturing: bioprocessing for growth and harvest of biopharmaceuticals
3 – Extraction of natural drug products from vegetable or animal tissues
Chemical Synthesis Process Overview
- Diagram shows an example of bulk aspirin manufacturing process.
- Series of chemical reactions in multipurpose reactors.
- Process flow from reactor to crystallizer, slurry tank, centrifuge, dump cart and rotary dryer.
- The products are isolated by extraction, crystallisation and filtration.
Process Workflow for Dosage-Form Products
- Drug substances are converted into dosage-form products before administration to humans or animals
- The active drug substances are mixed with excipients and processed to achieve the desired properties for final formulation.
- Tablets, pills and capsules are amongst the most common dosage forms.
- Biopharmaceutical manufacturing or Bioprocessing is divided into two broad areas:
- Upstream Bioprocessing
- Downstream Bioprocessing
- Microorganisms containing the chemical product are grown up to large scale, the product is then harvested and purified.
Differences between Batch, Fed-Batch, Continuous Cultures Upstream Bioprocessing
Product Recovery Methods – Filtration and Chromatography
Depth Filtration removes cell debris due to size exclusion as well as contaminants and unwanted particles